In addition to the variations connected to the plant variety, environmental influences such as the amount of sunshine and rain, seasonality and climate can have great impact on the composition of a medicinal plant. These factors cannot be avoided; their influence, however, on the final medicinal product can be controlled. Zeller ensures this by implementing a standardized and controlled manufacturing process, which can balance out certain variations in the plant raw material.
Each step in the production of a phyto-pharmaceutical determines the quality and efficacy of the final product. By defining validated parameters and complying with standard specifications, Zeller is able to achieve batch-to-batch consistency despite variations in the plant material.
Some extracts are standardized to one active compound that is known to be responsible for the efficacy of the phyto-pharmaceutical. Zeller’s Petasites hybridus extract Ze 339 for allergic rhinitis is such a “standardized extract”, where each tablet contains 8 mg of the active petasins. By controlling the amount of petasins in the final product, Zeller is able to eliminate any variations in the petasin concentration, independent of whether the plant used has a higher or lower petasins content.
In addition to standardized extracts, Zeller also produces “quantified extracts”, which are defined by the amount of an active compound group. For example, the Hypercium perforatum Ze 117 for the treatment of depressive symptoms is quantified based on the amount of hypericins.
For some phyto-pharmaceuticals, the active components responsible for efficacy are unknown. These extracts are categorized as “other extracts”, and they are defined by specific analytical markers as well as the manufacturing process. Zeller’s Vitex agnus-castus extract Ze 440 for the treatment of premenstrual syndrome, Cimicifuga racemosa extract Ze 450 for menopause and Valeriana officinalis / Humulus lupus extract Ze 91019 for sleep disorders fall into this category.